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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 795 CORONIS WAY, Ashwaubenon, WI, 54304
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004967419
- DUNS Number
- —
Catalogue (64)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Classic | Patient Kit | FDA UDI | N/A | Active |
| Classic | 36 Syringe Bulk Pack | FDA UDI | N/A | Active |
| Eure-Ca | Ten Syringe Pack | FDA UDI | N/A | Active |
| Forte | Patient Kit | FDA UDI | N/A | Active |
| Duet | Eight Syringe Pack | FDA UDI | N/A | Active |
| Nu TempCement NE | Two Syringe Kit | FDA UDI | Class II | Active |
| Nova | Small | FDA UDI | Class I | Active |
| Nu Form | Shade Bleach | FDA UDI | Class II | Active |
| Classic | Ten Syringe Pack | FDA UDI | N/A | Active |
| Nova | Large | FDA UDI | Class I | Active |
| Classic | 50 Syringe Pack | FDA UDI | N/A | Active |
| Nu Shield | 0.25 gram - 100 pack | FDA UDI | Class II | Active |
| Classic | Ten Syringe Pack | FDA UDI | N/A | Active |
| Sentry Dental TC&B | Shade A2 | FDA UDI | Class II | Active |
| Nova | Extra Small | FDA UDI | Class I | Active |
| Super Flex Nitrile Exam Gloves | Medium | FDA UDI | Class I | Active |
| Nu Form | Shade C2 | FDA UDI | Class II | Active |
| Nu Seal | 1 Syringe Kit | FDA UDI | Class II | Active |
| Classic | Ten Syringe Pack | FDA UDI | N/A | Active |
| Super Flex Nitrile Exam Gloves | Extra Small | FDA UDI | Class I | Active |
| Nova | Extra Large | FDA UDI | Class I | Active |
| Super Flex Nitrile Exam Gloves | Extra Large | FDA UDI | Class I | Active |
| Nu Shield | 0.4 gram - 200 pack | FDA UDI | Class II | Active |
| Blue Silk Nitrile Exam Gloves | extra large | FDA UDI | Class I | Active |
| Super Flex Nitrile Exam Gloves | Small | FDA UDI | Class I | Active |
| Nova | Medium | FDA UDI | Class I | Active |
| Classic | Maintenance Kit | FDA UDI | N/A | Active |
| Duet | 36 Syringe Bulk Pack | FDA UDI | N/A | Active |
| Classic | 50 Syringe Pack | FDA UDI | N/A | Active |
| Nu Shield | 0.4 gram - 100 pack | FDA UDI | Class II | Active |
| Blue Silk Nitrile Exam Gloves | large | FDA UDI | Class I | Active |
| Classic | Maintenance Kit | FDA UDI | N/A | Active |
| Classic | Patient Kit | FDA UDI | N/A | Active |
| Classic | 50 Syringe Pack | FDA UDI | N/A | Active |
| Forte | Touch Up Kit | FDA UDI | N/A | Active |
| Classic | Patient Kit | FDA UDI | N/A | Active |
| Nu Form | Shade A3 | FDA UDI | Class II | Active |
| Nu Form | Shade A1/B1 | FDA UDI | Class II | Active |
| Nu Form | Shade A2 | FDA UDI | Class II | Active |
| Super Flex Nitrile Exam Gloves | Large | FDA UDI | Class I | Active |
| Classic | 36 Syringe Bulk Pack | FDA UDI | N/A | Active |
| Nu Seal | 4 Syringe Kit | FDA UDI | Class II | Active |
| Forte | 36 Syringe Bulk Pack | FDA UDI | N/A | Active |
| Forte | Maintenance Kit | FDA UDI | N/A | Active |
| Sentry Dental TC&B | Shade Bleach | FDA UDI | Class II | Active |
| Classic | 36 Syringe Bulk Pack | FDA UDI | N/A | Active |
| Nu TempCement NE | One Syringe Kit | FDA UDI | Class II | Active |
| Sentry Dental TC&B | Shade A3 | FDA UDI | Class II | Active |
| Sentry Dental TC&B | Shade C2 | FDA UDI | Class II | Active |
| Classic | 36 Syringe Bulk Pack | FDA UDI | N/A | Active |
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